PACKAGE LEAFLET: INFORMATION FOR THE USER

SINCROVER 8 mg tablets, 16 mg tablets

Betahistine dihydrochloride
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sincrover is and what it is used for
What you need to know before taking Sincrover
How to take Sincrover
Possible side effects
How to store Sincrover
Contents of the pack and other information

1. What Sincrover is and what it is used for

Sincrover is a medicine used to treat Ménière's syndrome, the symptoms of which may include dizziness, ringing in the ears, hearing loss, and nausea.

2. What you need to know before taking Sincrover

Do not use Sincrover

If you are allergic to betahistine or to any of the other ingredients of this medicine, listed in section 6
If you have phaeochromocytoma, a rare tumour of the adrenal gland
If you are under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sincrover

If you have or have had gastric ulcer (peptic ulcer)
If you have asthma
If you have urticaria, skin rash or allergic rhinitis, as these conditions may worsen
if you have low blood pressure
if you are pregnant or planning to become pregnant
if you are breastfeeding

If you have any of the conditions listed above, consult your doctor to determine whether you can take
betahistine.
These patient groups must be monitored by a doctor during treatment.

Other medicines and Sincrover
An interaction refers to the influence that medicines or substances may have on the way each of them works,
or on the side effects when taken at the same time.
To date, no interactions between betahistine and other drugs have been observed.
Betahistine may influence the effect of antihistamines. Antihistamines are medicines used particularly for the treatment of allergies such as hay fever and motion sickness. If you are taking antihistamines (anti-allergy medicines) at the same time, consult your doctor or pharmacist.
Caution is advised when using betahistine concomitantly with MAO inhibitors. MAO inhibitors are drugs used particularly for the treatment of depression.
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those without a prescription.

Pregnancy and breastfeeding
It is not known whether the use of Sincrover during pregnancy is safe. For this reason, this medicine should not be used during pregnancy unless strictly necessary.
It is not known whether betahistine is excreted in breast milk. Therefore, it is advisable to discuss breastfeeding with your doctor. Your doctor can help you decide what is best for you and your baby after evaluating the benefits and risks associated with this medicine.
Ask your doctor or pharmacist for advice before taking this or any other medicine.

Driving and operating machinery
It is unlikely that Sincrover affects your ability to drive or operate machinery.
However, it is important to remember that the conditions requiring treatment with betahistine (vertigo, tinnitus, and hearing loss associated with Ménière's syndrome) may cause dizziness or discomfort and could affect your ability to drive or use machinery.

Sincrover contains monohydrate lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicinal product.

3. How to take Sincrover

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The usual dose is:
Adults
The usual initial dose is 1 or 2 tablets of 8 mg or half of one 16 mg tablet,
taken three times a day. The usual maintenance dose ranges between 24 and 48 mg daily.
It may take a couple of weeks before improvements become noticeable.
How to use
It is preferable to take the tablets with meals.
If you take more Sincrover than you should
If you have taken more than the prescribed dose, contact your doctor.
Symptoms of an overdose of betahistine up to 640 mg may be mild to moderate in intensity, such as nausea, drowsiness, vomiting, digestive disturbances, abdominal pain, and coordination problems. Taking higher doses of betahistine may cause more severe symptoms, including seizures, heart or lung problems, and epileptic attacks.
If you forget to take Sincrover
Wait until it is time for your next dose. Do not take a double dose to make up for the missed tablet.
If you have any questions about the use of Sincrover, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur more frequently (affecting up to 1 in 10 people):
Gastrointestinal tract
Nausea and dyspepsia
Nervous system
Headache

The frequency of the following side effects is unknown:
Skin
Hypersensitivity reactions (sometimes severe), edema, rash, pruritus
Gastrointestinal tract
Mild gastrointestinal disturbances (such as vomiting, gastrointestinal pain, bloating, nausea, digestive problems), which are generally resolved by taking the medicine during meals. Alternatively, the dose may be reduced on the advice of your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor.
You may also report side effects directly via the website:
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sincrover

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging
after "Do not use after" or "Exp". The expiry date refers to the last day of the month.
Store Sincrover in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sincrover contains
The active substance is betahistine dihydrochloride.
One tablet contains 8 mg of betahistine dihydrochloride.
One tablet contains 16 mg of betahistine dihydrochloride.
The other excipients are povidone, microcrystalline cellulose, monohydrate lactose, colloidal anhydrous silica, crospovidone and stearic acid.

Description of the appearance of Sincrover and contents of the pack
Sincrover 8 mg tablets: cylindrical, flat, white tablet with bevelled edges on both sides, marked "B8" on one side and smooth on the other side.
10 tablets in a blister, 5, 10 or 12 blisters in a cardboard box; or 14 tablets in a blister, 1 blister in a cardboard box.

Sincrover 16 mg tablets: cylindrical, flat, white tablet with bevelled edges on both sides, marked "B16" on one side and a break line on the other side. The tablet can be divided into two equal parts.
10 tablets in a blister, 2, 5 or 6 blisters in a cardboard box; or 14 tablets in a blister, 1, 3 or 6 blisters in a cardboard box.

Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER
Laboratorio Farmaceutico CT Srl
Strada Solaro 75-77
18038 Sanremo (IM)

Manufacturer responsible for batch release
Catalent Germany Schorndorf GmbH
Steinbeisstrasse, 2 - Schorndorf (Germany)

This medicinal product is authorised in the European Economic Area (EEA) countries
under the following names:
Belgium: Betahistine Sandoz 8 mg & 16 mg
Ireland: By-Vertin 8 mg & 16 mg
Italy: Sincrover, tablets 8 mg & 16 mg
Netherlands: Betahistine.2HCl Disphar 8 & 16, tabletten 8 mg & 16 mg